MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP; SCREWDRIVER SHAFT

Model Number	18911039
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the procedure, the tip of the erisma-lp screwdriver shaft #18911039 broke intraoperatively.The fragment was completely sunk in the screw head, so it was decided to leave it in place.It is important to note that once the rod implant is seated and locked into the tulip of the polyaxial screw, the fractured tip is prevented from dislodging as long as the rod remains firmly locked into place.The procedure was completed utilizing another screwdriver readily available in the set with no delay.Surgery was completed with no further complications.
Event or Problem Description
Screwdriver tip broke off inside the screw head.Sheared off completely so surgeon left the sheared fragment in place and locked rod down over top of it.
Additional Manufacturer Narrative
During the procedure, the tip of the erisma-lp screwdriver shaft #18911039 broke intraoperatively.The fragment was completely sunk in the screw head, so it was decided to leave it in place.It is important to note that once the rod implant is seated and locked into the tulip of the polyaxial screw, the fractured tip is prevented from dislodging as long as the rod remains firmly locked into place.The procedure was completed utilizing another screwdriver readily available in the set with no delay.Surgery was completed with no further complications.12/20/2019 - after analysis under a magnifying glass, it appears a net break of the tip of the shaft.Moreover, it is possible to notice a stop at the opposite of the break point.All striations are in the same direction.This break is characteristic of over-bending by the surgeon.
Event or Problem Description
Screwdriver tip broke off inside the screw head.Sheared off completely so surgeon left the sheared fragment in place and locked rod down over top of it.

• Brand Name: ERISMA-LP
• Common Device Name: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9799565
• Report Number: 3009962553-2019-00008
• Device Sequence Number: 19509083
• Product Code: HXX
• UDI-Device Identifier: 03700780625154
• UDI-Public: (01)03700780625154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 18911039
• Device Catalogue Number: 18911039
• Device Lot Number: H224X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR